Monitoring and Improving the Effectiveness of …

1 Monitoring and Improving the Effectiveness of Cleaning Medical and Surgical Devices: Ban the Biofilm!!Dr. Michelle J. Alfa, , FCCMM edical Director, Clinical Microbiology, Diagnostic Services of Manitoba, Winnipeg, CanadaDisclosures:Sponsored to give invited presentations at various National and International conferences by;STERIS, 3M, J&J, Healthmark, APIC, CACMID, Virox, Medisafe, Ontario Hospital Association, CHICA, and multiple conference associations. The University of Manitoba has licensed Dr. Alfa s patent for Artificial Test Soil to Leader Panel participation or Consulting Services for: 3M, J&J, STERIS, Serim, Olympus, bioMerieux, Serim, various Canadian Healthcare projects for:3M, STERIS, J&J, Novaflux, Virox, Serim, Olympus, Medisafe, Serim, Case Medical, Province of Manitoba, Public Health Agency of Canada (NOTE: no funds from these research projects comes to Dr.)

2 Alfa all funds handled by the St. Boniface Research Centre). Objectives: Manual vsAutomated Cleaning: - Roles for Manufacturers and Users Infection transmission: recent publications- Arthroscopic shavers- flexible endoscopes Monitoring cleaning- what to monitor?- how to monitor? SummaryPictures from Google ImagesMedical Device Cleaning: Centre Stage FDA:Draft FDA guidance: manufacturers to validate cleaning instructions [ ] Reprocessing: 2011 Summit; Priority issues from the AAMI/FDA Medical Device Reprocessing Summit [reprints: Horizons[AAMI publisher, Spring 2012 issue]:Sterilization and Reprocessing A Matter of Patient Safety[ ] NBC News: Dr. Nancy Snyderman[2012] automated versus Manual? Surgical Instruments: - Manual allows specific observation of problem areas but automated is more reproducible/effective for some instruments (Alfa et al 2006).]

3 flexible endoscopes-More Reproducible; compliance with guidelines: for manual for automated (OfsteadC. et al 2010) -More cost effective; automated saved 2 hrsstaff labour/day vsmanual (Forte L, Shum C 2011) Water quality: affects all cleaning- mineral content > 50ppm spotting on instruments- higher mineral content chemical cleaners less effective- final rinse water needs Monitoring (UeteraY et al 2012)How clean is clean enough? Cleaning ensures removal of:- organic residuals (secretions, skin, bone, etc)- microorganisms Proper cleaning ensures disinfection/sterilization will be effectivePictures from Google ImagesMANUAL/ automated :Need Rapid Cleaning Monitors to verify if cleaning has been : What do they say? ANSI/AAMI ST79:2011* Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.

4 AAMI publishers AAMI TIR30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. AAMI publishers Decontamination of reusable medical devices. CSA guideline Standards of Infection Control in Reprocessing of flexible Gastrointestinal endoscopes SGNA 2011.*Weekly (preferably daily) Monitoring of automated washer cleaning is recommended No specific recommendations for how to monitor manual cleaningAre Medical Devices a Patient Safety Problem?? Guidelines indicate the risk of infection transmission due to medical devices is very Outbreaks associated with medical devices have high transmission rates:-Arthroscopic shaver Pseudomonas aeruginosa infection (2011):-Duodenoscope Klebsiella pneumonia infection (2010):Arthroscopic Shavers: Tosh PG et al Outbreak of surgical site infections after arthroscopic procedures: Texas, 2009 ICHE 2011.

5 32 in 7 patients over ~ 2 weeks- Identical detected in water and suction canister [not detected in shavers]-Shaver handpiecesautoclaved Case Patients: 2 patients: ACL reconstruction4 patients: Knee debridement [ ] * * ** **Infections detected 4 19 days post knee surgeryRetained tissue in - cannula lumen - Handpiecesuction lumenTosh PG et al Outbreak of surgical site infections after arthroscopic procedures: Texas, 2009 ICHE 2011;32 Conclusions: Inadequate Cleaning: Tissue remains in lumen of handpiecedespite cleaning and sterilization Source of : tap water used for cleaning Autoclaving not adequate:cross-transmission of same strain occurred Transmission rate: 1,045 cases/10,000procedures ( ~1 in every 10 get infected) FDA issued a Safety Alert:encouraged inspection of lumens with 3mm videoscopeDuodenoscopeTransmission of KlebsiellapneumoniaeThe strain of was multi-resistantPictures from Google ImagesSimilar findings by: - Carbonne A et al Endoscopy 2010 (France) - Aumeran C.

6 Et al Euro Surveill 2010 (France) by DuodenoscopeCase:Date of duodenoscopySpecimenInfection/ colonizationOutcome1 Aug 1 Rectal swabColonizationSOURCE CASE9 Aug 18 Rectal swabColonizationAlive2 Aug 29 Blood InfectionDeath (unrelated to )8 Sept 1 Rectal swabColonizationAlive11 Sept 3 Rectal swabColonizationDeath (unrelated to )3 Sept 14 BloodInfectionDeath (unrelated to )10 Sept 15 Rectal swabColonizationAlive13 Sept 28 Rectal swabColonizationAliveCarbonne A et al Control of multi-hospital outbreak of KPC-producing K. pneumoniae type 2 in France. Euro Surveill 2010;15(48)pli=19734 Key Conclusions Endoscope cultures grew Not all transmissions resulted in infections (45% transmission rate from same scope) Cleaning and disinfection (Peraceticacid) done properly Drying inadequate multiple rounds of cleaning and HLD [?]

7 Biofilm]Carbonne A et al Control of multi-hospital outbreak of KPC-producing K. pneumoniae type 2 in France. Euro Surveill 2010;15(48)pli=19734 What commercial rapid monitors are available to assess cleaning efficacy of automated washers?Pictures from Google ImagesCleaning Monitors for automated Washers MedisafeLumen check: Laparoscopic device lumen Flexi check: Endoscope lumen HealthMarkUSA, MedisafeUK, Steris/ Browne UK, SteriTec, USA, Serim, USA TOSI LumchekThese represent some examples it is NOT an all-inclusive listSteritecWash-ChecksPictures from company websites or Google imagesThese monitors assess how effective the washer function is: ISO TC 198 WG13 is working to standardize washer cleaning Monitoring and develop testing methods that allow test soil comparisonTOSI STF Load checkSonocheckEnzymatic Detergent testFrequency of Monitoring ?

8 ? Quality Assurance Program: ANSI/ AAMI ST79 recommends weekly (preferably daily) Monitoring of mechanical washer cleaning efficacy Site implementation: - Establish site baseline: initial daily testing of all automated washers for a short period of time- Ongoing each washer tested minimally 1/week Published data needed:- Comparisons of various cleaning monitors- Impact of Monitoring on Improving detection of faulty washer cleaning function Pictures from Google ImagesManual Cleaning: What monitors are available?Narrow lumened instruments( flexible endoscopes)Surgical instruments:( fragile, lock box,retractable parts etc)Pictures from Google Images19 Rapid Audit Tools: Manual residuals: [Protein, Hemoglobin most common]- Alfa et al 2010: Medical Device washers (Protein)- Witfield2011: flexible endoscopes; ChannelCheck(Hemoglobin, Protein, Carbohydrate) : [Medical Device.]

9 New application]- Obeeet al 2005: flexible endoscopes < 500 RLU- Alfa et al 2012: flexible endoscopes < 200 RLUAAMI TIR 12:2010 and AAMI TIR 30:2003 Benchmarks: protein: < g/ cm2, hem oglobin< g/ cm2 Endoscope Lumens: Rapid Manual Cleaning MonitorsChannel Chek: Healthmark 3 MPictures from company websitesTests assess how well the manual cleaning is being done by staffChannel SampleCarbohydrate, protein, hemoglobinDetects ATPAlfa et al 2012 AJIC; two studies: ATP validation for endoscope channelsAlfa et al 2012 AJIC: Organic residual test validation for endoscope channelsTrans-Canada Survey: patient-ready flexible endoscopesNo:Pos:CarbohydrateProteinBloodGastroscope54350 ( )0347 Colonoscope46332 ( )5225 Bronchoscope25110 (4%)0010 ERCP scope577 ( )007[Elevator wire]214 ( )004 Sigmoidoscope912 ( )002 Rapid Cleaning test for Carbohydrate, Protein, BloodClinical Study: ATP to monitor manual cleaning of endoscopesColonoscopesPost manual cleaning (N = 20):L1: 0% > 200 RLUsL2: 0% > 200 RLUsL3: 0% > 200 RLUsDuodenoscopesPost manual cleaning (N = 20):L1: 0% > 200 RLUsL2: 0% > 200 RLUsL4.

10 20% > 200 RLUs (all < 700 RLUs)Validated cut-off for adequate cleaning = < 200 RLUsManufacturer Validation of Manual Cleaning Monitors: Which channels to monitor? How should channel sample be collected:- Realistic in busy clinic- Liquid: volume, type of liquid- Sponge or brush sample method? Benchmark for adequate clean:- relate to clean benchmarks to be achievedCSAO Endoscope ReprocessingSome AERs: cleaning cycle replaces manual cleanWhat stage should be monitored and how?Manual cleaning:ATP or OrganicHLD:Organic or Viable countStorage:Viable countStop Dirty Instruments at the Cleaning stage!! Once disinfected or sterilized residues are fixed hard to extract and analyze Need to do routine Monitoring of cleaning to prevent build up of fixed material on J, Basile RJ The need to verify the cleaning process.